FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING
K Number: K964955
·
Decision Feb 14, 1997
Classifications
1
FEI Numbers
91
Registration Numbers
91
Same Product Code
42
Applicant Total
20
Review Days
65
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Basic Information
- Device Name
- FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING
- K Number
- K964955
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Flexmedics
- Date Received
- December 11, 1996
- Decision Date
- February 14, 1997
- Product Code
- OCY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Flexmedics
| K Number | Device Name | ||
|---|---|---|---|
| K990765 | FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO | Mar 15, 1999 | Substantially Equivalent |
| K952430 | FINESSE GUIDEWIRE CORONARY | Aug 18, 1995 | Substantially Equivalent |
| K943390 | FLEXFINDER GUIDEWIRE | Jun 27, 1995 | Substantially Equivalent |
| K942074 | FLEXFINDER GUIDEWIRE | Jun 24, 1994 | Substantially Equivalent |
| K934265 | FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE | Jan 21, 1994 | Substantially Equivalent |
| K912843 | FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE | Sep 24, 1991 | Substantially Equivalent |
| K910674 | FLEXMEDICS MALLEABLE CANNULA | Apr 12, 1991 | Substantially Equivalent |
| K895899 | FLEXMEDICS GUIDEWIRE .012 ONLY | May 23, 1990 | Substantially Equivalent |
| K893626 | FLEXMEDICS GUIDEWIRE | Sep 26, 1989 | Substantially Equivalent |
| K885086 | TIN COATED NITI ORTHODONTIC ARCH WIRES | Jan 10, 1989 | Substantially Equivalent |